A Study of Tirzepatide (LY3298176) Once Weekly in Adolescent Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Efficacy, Safety, and Pharmacokinetics of Tirzepatide Once Weekly Versus Placebo in Adolescent Participants Who Have Obesity, or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (SURMOUNT-ADOLESCENTS)
3 other identifiers
interventional
150
6 countries
33
Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity or overweight with at least one weight-related comorbidity. The study will last approximately 90 weeks and may include up to 25 visits. Participants who have completed the primary 72-week GPHP study and have been off treatment for no more than 12 weeks (including the 4-week safety follow-up period), will have the opportunity to receive an additional 156 weeks of treatment with tirzepatide as well as continuing the lifestyle intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
Started Oct 2023
Longer than P75 for phase_3 obesity
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2023
CompletedFirst Posted
Study publicly available on registry
October 10, 2023
CompletedStudy Start
First participant enrolled
October 16, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
ExpectedJune 25, 2025
June 1, 2025
2.5 years
October 4, 2023
June 20, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Mass Index (BMI)
Baseline, Week 72
Secondary Outcomes (11)
Percentage of Participants with ≥5% BMI Reduction
Baseline, Week 72
Change from Baseline in Body Weight
Baseline, Week 72
Change from Baseline in Waist Circumference
Baseline, Week 72
Change in Impact of Weight on Quality of Life (IWQOL)-Kids Physical Comfort Domain Score
Baseline, Week 72
Change from Baseline in Body Weight Percentile based on Sex and Age-specific Growth Charts
Baseline, Week 72
- +6 more secondary outcomes
Study Arms (2)
Tirzepatide
EXPERIMENTALParticipants will receive tirzepatide subcutaneously (SC).
Placebo
PLACEBO COMPARATORParticipants will receive placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Have obesity, as defined by BMI equal to or above the 95th percentile for age and sex, on age- and sex-specific growth chart, OR
- Have overweight, as defined by BMI equal to or above the 85th percentile but less than the 95th percentile for age and sex, on age- and sex-specific growth chart, with at least 1 weight-related comorbidity.
- dyslipidemia
- pre-hypertension
- hypertension
- nonalcoholic fatty liver disease
- obstructive sleep apnea
- prediabetes
- documented preexisting condition of Type 2 Diabetes
- Participants with Type 2 Diabetes Mellitus (T2DM)
- Have been treated with either diet and exercise alone or stable treatment with metformin for at least 90 days prior to screening and have a HbA1c\<9.0%
You may not qualify if:
- Have a self-reported, or by parent or legal guardian where applicable, decrease in body weight more than 5 kilogram (kg) (11 lbs.) within 90 days before screening irrespective of medical records.
- Have Type 1 Diabetes
- Have taken within 90 days before screening or intend to start prescribed or over-the-counter medications, or alternative remedies including herbal or nutritional supplements, intended to promote body weight reduction.
- Are prepubertal (Tanner stage 1).
- Have a family or personal history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia (MEN) Syndrome Type 2
- Have a history of chronic or acute pancreatitis.
- Have undergone or plan to undergo weight reduction procedure during the study, such as, but not limited to
- gastric bypass
- sleeve gastrectomy
- restrictive bariatric surgery, such as Lap-Band gastric banding, or
- any other procedure intended to result in weight reduction.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
CenExel iResearch, LLC
Decatur, Georgia, 30030, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
Barry J. Reiner, MD, LLC
Baltimore, Maryland, 21229, United States
M Health Fairview - Delaware Clinical Research Unit (DCRU)
Minneapolis, Minnesota, 55414, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Aventiv Research Inc
Columbus, Ohio, 43213, United States
PriMED Clinical Research
Dayton, Ohio, 45429, United States
Vanderbilt Health One Hundred Oaks
Nashville, Tennessee, 372212, United States
Alberta Diabetes Institute
Edmonton, Alberta, T6G 2E1, Canada
The Wharton Medical Clinic Clinical Trials Inc
Hamilton, Ontario, L8L 5G8, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
CIUSSS- saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, G7H 5H6, Canada
ReFit Clinic
Olomouc, Olomoucký kraj, 779 00, Czechia
Nemocnice AGEL Ostrava - Vitkovice a.s.
Ostrava, Ostrava Město, 703 84, Czechia
Fakultni nemocnice v Motole
Prague, Praha 5, 150 06, Czechia
Nemocnice Jihlava
Jihlava, 58633, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Yitzhak Shamir Medical Center
Beer Yaacov, Central District, 70300, Israel
Schneider Children's Medical Center
Petah Tikva, Central District, 4920235, Israel
Sheba Medical Center
Ramat Gan, Central District, 5262100, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9013102, Israel
Emek Medical Center
Afula, Northern District, 1834111, Israel
Rambam Health Care Campus
Haifa, Northern District, 3109601, Israel
Soroka Medical Center
Beersheba, Southern District, 8410101, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento
Verona, Veneto, 37126, Italy
Azienda Ospedaliera Universitaria Di Messina G. Martino
Messina, 98125, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità
Novara, 28100, Italy
Instytut Diabetologii
Warsaw, Masovian Voivodeship, 02-117, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 SUM
Zabrze, Silesian Voivodeship, 41-800, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi, Uniwersyteckie Centrum Pediatrii im. M. Konop -T
Lodz, Łódź Voivodeship, 91-738, Poland
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2023
First Posted
October 10, 2023
Study Start
October 16, 2023
Primary Completion
May 1, 2026
Study Completion (Estimated)
July 1, 2029
Last Updated
June 25, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.